The company said this marks a step toward bringing a new standard of care in dialysis therapy to the U.S. Bad Homburg, Germany-based Fresenius can now begin U.S.-based clinical evaluations and user studies ahead of a broad launch in 2025.

Fresenius’ 5008X system offers industry-leading, high-volume hemodiafiltration dialysis therapy. Along with the companion FX CorAL dialyzer, it combines the latest device engineering and cutting-edge membrane technologies. The company says these technologies make high-volume hemodiafiltration possible.